Phase 3
N=391
A Phase 3 Study of Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
Relapsed or Refractory Chronic Lymphocytic Leukemia · Small Lymphocytic Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT01578707 ↗Enrolled (actual)
391
Serious AEs
51.8%
Results posted
Oct 2015
Primary outcome: Primary: PFS (Progression Free Survival) by Independent Review Committee (IRC), Limited to the Time of Primary Analysis 06 November 2013 — 8.1; NA months — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ofatumumab (Drug); ibrutinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pharmacyclics LLC.
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PFS (Progression Free Survival) by Independent Review Committee (IRC), Limited to the Time of Primary Analysis 06 November 2013 |
8.1; NA | <0.0001 sig |
| SECONDARY Overall Response Rate (ORR) by Independent Review Committee (IRC) |
4.1; 42.6 | <.0001 sig |
| SECONDARY OS (Overall Survival) |
65.1; 67.7 | 0.1653 |
| SECONDARY Rate of Sustained Hemoglobin and Platelet Improvement |
32.6; 69.7; 9.4; 78.4 | — |
Summary
The purpose of the study is to evaluate whether treatment with ibrutinib as a monotherapy results in a clinically significant improvement in progression free survival (PFS) as compared to treatment with ofatumumab in patients with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
Eligibility Criteria
Inclusion Criteria
- ECOG performance status of 0-1.
- Diagnosis of CLL or SLL that meets IWCLL 2008 criteria.
- Active disease meeting at least 1 of the IWCLL 2008 criteria for requiring treatment.
- Must have received at least one prior therapy for CLL/SLL.
- Considered not appropriate for treatment or retreatment with purine analog based therapy.
- Measurable nodal disease by CT.
- Patients must be able to receive outpatient treatment and laboratory monitoring at the institution that administers study drug for the entire study.
Exclusion Criteria
- Known CNS lymphoma or leukemia.
- No documentation of cytogenetic and/or FISH in patient records prior to first dose of study drug.
- Any history of Richter's transformation or prolymphocytic leukemia.
- Uncontrolled Autoimmune Hemolytic Anemia (AIHA) or idiopathic thrombocytopenia purpura (ITP).
- Prior exposure to ofatumumab or to ibrutinib.
- Prior autologous transplant within 6 months prior to first dose of study drug.
- Prior allogeneic stem cell transplant within 6 months or with any evidence of active graft versus host disease or requirement for immunosuppressants within 28 days prior to first dose of study drug.
- History of prior malignancy, with the exception of certain skin cancers and malignancies treated with curative intent and with no evidence of active disease for more than 3 years.
- Serologic status reflecting active hepatitis B or C infection.
- Unable to swallow capsules or disease significantly affecting gastrointestinal function.
- Uncontrolled active systemic fungal, bacterial, viral, or other infection.
- History of stroke or intracranial hemorrhage within 6 months prior to the first dose of study drug.
- Requires anticoagulation with warfarin.
Data sourced from ClinicalTrials.gov (NCT01578707). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.